FEXOFENADINE CIPLA 120 MG FILM-COATED TABLETS EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fexofenadine Cipla 120 mg Film-coated Tablets EFG

Fexofenadine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Fexofenadine Cipla 120 mg is and what it is used for
2. What you need to know before taking Fexofenadine Cipla
3. How to take Fexofenadine Cipla 120 mg
4. Possible side effects
5. How to store Fexofenadine Cipla 120 mg
6. Contents of the pack and other information

1. What Fexofenadine Cipla 120mg is and what it is used for

Fexofenadine Cipla 120 mg contains fexofenadine hydrochloride, which is an antihistamine.

Fexofenadine Cipla 120 mg is used in adults and adolescents aged 12 years and older for the relief of symptoms associated with hay fever (seasonal allergic rhinitis), such as sneezing, runny, itchy or blocked nose, and itchy, red, watery eyes.

2. What you need to know before taking Fexofenadine Cipla 120 mg

Do not take Fexofenadine Cipla:

• if you are allergic to fexofenadine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Fexofenadine Cipla if:

• you have problems with liver or kidney function
• you have or have had heart disease, as this type of medicine may cause irregular or faster heartbeat
• you are an elderly patient.

Children and adolescents

Fexofenadine Cipla 120 mg film-coated tablets are not recommended for children and adolescents under 12 years of age.

Taking Fexofenadine Cipla with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you are taking apalutamide (a medicine used to treat prostate cancer), the effect of fexofenadine may be reduced.

Indigestion remedies containing aluminium and magnesium may interfere with the action of Fexofenadine Cipla by reducing the amount of drug absorbed.

It is recommended to leave a 2-hour interval between taking Fexofenadine Cipla and the indigestion remedy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Fexofenadine Cipla during pregnancy unless absolutely necessary.

Fexofenadine Cipla is not recommended during breastfeeding.

Driving and using machines

Fexofenadine Cipla 120 mg tablets are unlikely to affect your ability to drive or use machines. However, make sure these tablets do not make you feel drowsy or dizzy before driving or operating machinery.

Fexofenadine Cipla contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”.

3. How to take Fexofenadine Cipla 120 mg

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Adults and adolescents aged 12 years and older

The recommended dose is one tablet (120 mg) daily.

Take the tablet with water before a meal.

This medicine starts relieving your symptoms within 1 hour and lasts for 24 hours.

Use in children and adolescents

Fexofenadine is not recommended for children or adolescents under 12 years of age.

If you take more Fexofenadine Cipla than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose in adults include dizziness, drowsiness, fatigue, and dry mouth.

If you forget to take Fexofenadine Cipla

Do not take a double dose to make up for forgotten doses.

Take the next dose at the scheduled time as prescribed by your doctor.

If you stop taking Fexofenadine Cipla

Consult your doctor if you wish to stop taking fexofenadine before completing the treatment course.

If you stop taking fexofenadine earlier than planned, your symptoms may return.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Contact your doctor immediately and stop taking Fexofenadina Cipla if you experience:

Swelling of the face, lips, tongue or throat, and difficulty breathing, as these may be signs of a serious allergic reaction.

The following adverse effects have also been reported:

Common side effects (may affect up to 1 in 10 people):

• Headache
• Drowsiness
• Nausea
• Dizziness

Uncommon side effects (may affect up to 1 in 100 people):

• Fatigue
• Drowsiness

Frequency not known (cannot be estimated from the available data):

• Difficulty sleeping (insomnia)
• Sleep disorders
• Nightmares
• Nervousness
• Fast or irregular heartbeats
• Diarrhea
• Hives and itching
• Rash
• Severe allergic reactions which may cause swelling of the face, lips, tongue or throat, flushing, tightness in the chest and difficulty breathing
• Blurred vision

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fexofenadine Cipla 120mg

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label/carton/blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fexofenadine Cipla 120 mg

• The active substance is fexofenadine hydrochloride. Each film-coated tablet contains 120 mg of fexofenadine hydrochloride.
• The other components are:
  • Tablet core: microcrystalline cellulose, corn starch, sodium croscarmellose, povidone, and magnesium stearate.
  • Film coating: hypromellose, titanium dioxide (E 171), macrogol, yellow iron oxide (E 172), and red iron oxide (E 172).

Appearance of the product and contents of the pack

Fexofenadine Cipla 120 mg are film-coated tablets, peach-colored, oblong, biconvex, and smooth on both sides. Dimensions: 15.00 mm x 6.5 mm.

They are packed in PVC/PVDC/Al blisters in cardboard boxes containing 7, 10, 15, 20, 30, 50, 100 and 200 (as 10x20) tablets per package.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Cipla Europe NV
De Keyserlei 60C, Bus-1301,
2018 Antwerp, Belgium

Manufacturer:

Cipla Europe NV
De Keyserlei 60C, Bus-1301,
2018 Antwerp, Belgium

S&D Pharma CZ, spol.s r.o,
Theodor 28, Pchery (Pharmos a.s. facility),
27308 Czech Republic

Local Representative:

Cipla Europe NV, Spanish branch
C/Guzmán el Bueno, 133, Edif. Britannia - 28003 - Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: 02/2023